Status:
UNKNOWN
Pediatric Prospective Personalized Immune and Target Identification Trial
Lead Sponsor:
Masaryk University
Collaborating Sponsors:
Brno University Hospital
Roche s.r.o.
Conditions:
Central Nervous System Neoplasms
Pediatric Cancer
Eligibility:
All Genders
1-19 years
Phase:
NA
Brief Summary
PPROSPERITIT is a prospective clinical study assessing the use of comprehensive molecular profiling to define the best matching targeted and immune treatment for relapsed, refractory or very high risk...
Detailed Description
PPROSPERITIT will identify specific molecular changes by using genomic sequencing technologies in refractory/recurrent or very high-risk pediatric CNS tumors. The study will employ an analytically val...
Eligibility Criteria
Inclusion
- Patient Informed consent form must be appropriately obtained under the applicable local and regulatory requirements. Each patient must sign a consent form prior the enrollment to document their willingness to participate.
- The subject is male or female, aged 1 - 19 years
- The subject must have a histologically proven recurrent/ refractory or very high-risk CNS tumors
- Patients must be in good overall physical condition, which allows tumor biopsy
- Patients must have a life expectancy of at least 3 months.
- Patients must have a tumor amenable to image-guided or direct vision biopsy and be willing and able to undergo a tumor biopsy and/or blood taking for molecular profiling.
- Patients must be accessible for follow-up.
Exclusion
- Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant and/or breastfeeding women, if applicable
- No intention to treat the patient.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04859543
Start Date
February 1 2021
End Date
December 31 2024
Last Update
April 26 2021
Active Locations (2)
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1
University Hospital Brno
Brno, Czechia, 62500
2
Motol University Hospital
Prague, Czechia